Att B - 60d FRN

37265

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collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Prevent Hepatitis Transmission Among
Persons Who Inject Drugs—New—
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease
Control and Prevention (CDC)
Background and Brief Description
Hepatitis C virus (HCV) infection is
the most common chronic blood borne
infection in the United States;
approximately 3 million persons are
chronically infected. Identifying and
reaching persons at risk for HCV
infection is critical to prevent
transmission and treat and cure if
infected. CDC monitors the national
incidence of acute hepatitis C through
passive surveillance of acute,
symptomatic cases of laboratory
confirmed hepatitis C cases. Since 2006,
surveillance data have shown a trend
toward reemergence of HCV infection
mainly among young persons who inject
drugs (PWID) in nonurban counties. Of
the cases reported in 2013 with
information on risk factors 62%
indicated injection drug use as the

primarily through drug treatment
programs and syringe exchange
programs, as well as persons referred to
these sites as a result of referral from
other programs and respondent driven
sampling. Those who consent to
participate will be administered an
eligibility interview questionnaire by
trained field staff. If found eligible, the
participant will take an intervieweradministered survey that includes
information on initiation of drug use,
injection practices, HCV and HIV
infection status, access to prevention
and medical care, desire to receive and
barriers to receiving HCV treatment, and
missed opportunities for hepatitis
prevention. Participants will receive
counselling regarding adherence to
medical and/or drug treatment services
and prevention services. Participants
will be interviewed for a maximum of
5 times within any 12-month interval
during the course of the study: Consent
and interview at enrollment/baseline for
an estimated 60 minutes, and 30-minute
follow-up interviews every 3 months
thereafter. Participants who are
recruited early in the study have more
follow-up interviews than those who are
recruited in the later part of the study
during the 3-year project. However,
recruitment will be spread over 2 years
and on average, the duration of followup is estimated to be one year.
Participation in interviews and
responses to all study questions are
totally voluntary and there is no cost to
respondents other than their time. The
maximum burden is 3,375 hours.

primary risk for acute hepatitis C. The
prevention of HCV infection among
PWIDs requires an integrated approach
including harm reduction interventions,
substance abuse treatment, prevention
of other blood borne infections, and care
and treatment of HCV infection.
The purpose of the proposed study is
to address the high prevalence of HCV
infection by developing and
implementing an integrated approach
for detection, prevention, care and
treatment of infection among persons
aged 18–30 years who reside in nonurban counties. Awardees will develop
and implement a comprehensive
strategy to enroll young non-urban
PWID, collect epidemiological
information, test for HCV infection and
provide linkage to primary care services,
prevention interventions, and treatment
for substance abuse and HCV infection.
In addition to providing HCV testing,
participants will be offered testing for
the presence of co-infections with
hepatitis B virus (HBV) and HIV. Rates
of HCV infection or re-infection will be
evaluated through follow-up blood tests.
Furthermore, adherence to prevention
services and retention in care will be
assessed through follow up interviews.
The project will recruit an estimated
total of 1,500 young PWIDs to enroll
1,000. The participants will be recruited
from settings where young PWIDs
obtain access to care and treatment
services. Recruitment will be direct and
in-person by partnering with local harm
reduction sites. Recruiters will enroll
subjects across recruitment sites

asabaliauskas on DSK5VPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents

Number of
responses per
respondent

Average
burden per
response
(in hrs.)

Total burden
(in hrs.)

Type of respondents

Form name

Young PWIDs ...................................
Eligible young PWIDs .......................
Eligible young PWIDs .......................

Screener ...........................................
Initial Survey .....................................
Follow-up survey ..............................

1500
1000
1000

1
1
4

15/60
60/60
30/60

375
1000
2000

Total ...........................................

...........................................................

........................

........................

........................

3375

Maryam I. Daneshvar,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

[FR Doc. 2015–16027 Filed 6–29–15; 8:45 am]

[60Day–15–0666; Docket No. CDC–2015–
0048]

BILLING CODE 4163–18–P

Centers for Disease Control and
Prevention

Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).

AGENCY:

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ACTION:

Notice with comment period.

The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on the National Healthcare
Safety Network (NHSN). NHSN is a

SUMMARY:

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37266

Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices

system designed to accumulate,
exchange, and integrate relevant
information and resources among
private and public stakeholders to
support local and national efforts to
protect patients and promote healthcare
safety.
DATES: Written comments must be
received on or before August 31, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0048 by any of the following methods:
• Federal eRulemaking Portal:
Regulation.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.

To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: [email protected].
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA also
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
FOR FURTHER INFORMATION CONTACT:

accumulate, exchange, and integrate
relevant information and resources
among private and public stakeholders
to support local and national efforts to
protect patients and promote healthcare
safety. Specifically, the data is used to
determine the magnitude of various
healthcare-associated adverse events
and trends in the rates of these events
among patients and healthcare workers
with similar risks. The data will be used
to detect changes in the epidemiology of
adverse events resulting from new and
current medical therapies and changing
risks. The NHSN currently consists of
five components: Patient Safety,
Healthcare Personnel Safety,
Biovigilance, Long-Term Care Facility
(LTCF), and Dialysis. The Outpatient
Procedure Component is on track to be
released in NHSN in 2016/2017. The
development of this component has
been previously delayed to obtain
additional user feedback and support
from outside partners.
Changes were made to seven facility
surveys. Based on user feedback and
internal reviews of the annual facility
surveys it was determined that
questions and response options be
amended, removed, or added to fit the
evolving uses of the annual facility
surveys. The surveys are being
increasingly used to help intelligently
interpret the other data elements
reported into NHSN. Currently the
surveys are used to appropriately risk
adjust the numerator and denominator
data entered into NHSN while also
guiding decisions on future division
priorities for prevention.
Additionally, minor revisions have
been made to 27 forms within the
package to clarify and/or update
surveillance definitions. Two forms are
being removed as those forms will no
longer be added to the NHSN system.
The previously approved NHSN
package included 54 individual
collection forms; the current revision
request removes two forms for a total of
52 forms. The reporting burden will
increase by 583,825 hours, for a total of
4,861,542 hours.

extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
ways to enhance the quality, utility, and
clarity of the information to be
collected; (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology; and (e) estimates of capital
or start-up costs and costs of operation,
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
National Healthcare Safety Network
(NHSN)—Revision—National Center for
Emerging and Zoonotic Infection
Diseases (NCEZID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
The National Healthcare Safety
Network (NHSN) is a system designed to

asabaliauskas on DSK5VPTVN1PROD with NOTICES

ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondents

Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).

VerDate Sep<11>2014

Number of
respondents

Form name

Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

(Infection

NHSN Registration Form .................

2,000

1

5/60

167

(Infection

Facility Contact Information .............

2,000

1

10/60

333

(Infection

Patient Safety Component—Annual
Hospital Survey.

5,000

1

50/60

4,167

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37267

Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent

Average
burden per
response
(in hours)

Total burden
(in hours)

Form name

Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................

Group Contact Information ...............

1,000

1

5/60

83

Patient Safety Monthly Reporting
Plan.
Primary Bloodstream Infection (BSI)

6,000

12

15/60

18,000

6,000

44

30/60

132,000

Pneumonia (PNEU) ..........................

6,000

72

30/60

216,000

Ventilator-Associated Event .............

6,000

144

25/60

360,000

Urinary Tract Infection (UTI) ............

6,000

40

20/60

80,000

Denominators for Neonatal Intensive
Care Unit (NICU).
Denominators for Specialty Care
Area (SCA)/Oncology (ONC).
Denominators for Intensive Care
Unit (ICU)/Other locations (not
NICU or SCA).
Surgical Site Infection (SSI) .............

6,000

9

3

162,000

6,000

9

5

270,000

6,000

60

5

1,800,000

6,000

36

35/60

126,000

Denominator for Procedure ..............
Antimicrobial Use and Resistance
(AUR)-Microbiology Data Electronic Upload Specification Tables.
Antimicrobial Use and Resistance
(AUR)-Pharmacy Data Electronic
Upload Specification Tables.
Central Line Insertion Practices Adherence Monitoring.
MDRO or CDI Infection Form ..........

6,000
6,000

540
12

5/60
5/60

270,000
6,000

6,000

12

5/60

6,000

1,000

100

25/60

41,667

6,000

72

30/60

216,000

MDRO and CDI Prevention Process
and Outcome Measures Monthly
Monitoring.
Laboratory-identified MDRO or CDI
Event.
Long-Term Care Facility Component—Annual Facility Survey.
Laboratory-identified MDRO or CDI
Event for LTCF.
MDRO and CDI Prevention Process
Measures Monthly Monitoring for
LTCF.
Urinary Tract Infection (UTI) for
LTCF.
Monthly Reporting Plan for LTCF ....

6,000

24

15/60

36,000

6,000

240

30/60

720,000

250

1

1

250

250

8

15/60

500

250

12

5/60

250

250

9

30/60

1,125

250

12

5/60

250

Denominators for LTCF Locations ...

250

12

3.25

9,750

Prevention
Process
Measures
Monthly Monitoring for LTCF.
LTAC Annual Survey .......................

250

12

5/60

250

400

1

50/60

333

Rehab Annual Survey ......................

1,000

1

50/60

833

Healthcare Personnel Safety Component Annual Facility Survey.
Healthcare Personnel Safety Monthly Reporting Plan.
Healthcare Worker Demographic
Data.
Exposure to Blood/Body Fluids ........
Healthcare Worker Prophylaxis/
Treatment.
Follow-Up Laboratory Testing ..........
Healthcare Worker Prophylaxis/
Treatment-Influenza.

50

1

8

400

17,000

1

5/60

1,417

50

200

20/60

3,333

50
50

50
30

1
15/60

2,500
375

50
50

50
50

15/60
10/60

625
417

Staff RN ............................................
Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Laboratory Technician ......................
Pharmacy Technician .......................
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).

(Infection

Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).
Registered
Nurse
Preventionist).

(Infection

(Infection
(Infection

(Infection
(Infection
(Infection

Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Registered
Nurse
(Infection
Preventionist).
Occupational Health RN/Specialist ...
asabaliauskas on DSK5VPTVN1PROD with NOTICES

Number of
respondents

Type of respondents

Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Occupational Health RN/Specialist ...
Laboratory Technician ......................
Occupational Health RN/Specialist ...

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Federal Register / Vol. 80, No. 125 / Tuesday, June 30, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Form name

Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Medical/Clinical Laboratory Technologist.
Staff RN ............................................

Hemovigilance Module Annual Survey.
Hemovigilance Module Monthly Reporting Plan.
Hemovigilance Module Monthly Reporting Denominators.
Hemovigilance Adverse Reaction ....

Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Registered
Nurse
(Infection
Preventionist).
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Staff RN ............................................
Total ...........................................

Total burden
(in hours)
2

1,000

500

12

1/60

100

500

12

1

6,000

500

48

15/60

6,000

Hemovigilance Incident ....................

500

10

10/60

833

Patient Safety Component—Annual
Facility Survey for Ambulatory
Surgery Center (ASC).
Outpatient Procedure Component—
Monthly Reporting Plan.
Outpatient Procedure Component
Event.
Outpatient Procedure Component—
Monthly Denominators and Summary.
Outpatient Dialysis Center Practices
Survey.
Dialysis Monthly Reporting Plan ......
Dialysis Event ...................................
Denominators for Dialysis Event
Surveillance.
Prevention
Process
Measures
Monthly Monitoring for Dialysis.
Dialysis Patient Influenza Vaccination.
Dialysis Patient Influenza Vaccination Denominator.

5,000

1

5/60

417

5,000

12

15/60

15,000

5,000

25

40/60

83,333

5,000

12

40/60

40,000

6,500

1

2.0

13,000

6,500
6,500
6,500

12
60
12

5/60
25/60
10/60

6,500
162,500
13,000

1,500

12

1.25

22,500

325

75

10/60

4,063

325

5

10/60

271

...........................................................

........................

........................

........................

4,861,542

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES (HHS)
Centers for Medicare and Medicaid
Services
Notice of Hearing: Reconsideration of
Disapproval Texas Medicaid State Plan
Amendment (SPA) 14–25
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Notice of Hearing:
Reconsideration of Disapproval.
AGENCY:

This notice announces an
administrative hearing to be held on
August 6, 2015, at the Department of
Health and Human Services, Centers for
Medicare and Medicaid Services,
Division of Medicaid & Children’s

SUMMARY:

17:34 Jun 29, 2015

Average
burden per
response
(in hours)

1

[FR Doc. 2015–16028 Filed 6–29–15; 8:45 am]

VerDate Sep<11>2014

Number of
responses per
respondent

500

Maryam I. Daneshvar,
Deputy Director, Office of Scientific Integrity,
Office of the Associate Director for Science,
Office of the Director, Centers for Disease
Control and Prevention.

asabaliauskas on DSK5VPTVN1PROD with NOTICES

Number of
respondents

Type of respondents

Jkt 235001

Health, Dallas Regional Office, 1301
Young Street, Room 714, Dallas, TX
75202, to reconsider CMS’ decision to
disapprove Texas’ Medicaid SPA 14–25.
Closing Date: Requests to participate
in the hearing as a party must be
received by the presiding officer by July
15, 2015.
FOR FURTHER INFORMATION CONTACT:
Benjamin R. Cohen, Presiding Officer,
CMS, 2520 Lord Baltimore Drive, Suite
L, Baltimore, Maryland 21244;
Telephone: (410) 786–3169.
SUPPLEMENTARY INFORMATION: This
notice announces an administrative
hearing to reconsider CMS’ decision to
disapprove Texas’ Medicaid SPA 14–25,
which was submitted to the Centers for
Medicare and Medicaid Services (CMS)
on August 26, 2014 and disapproved on
April 7, 2015. In part, this SPA
requested CMS approval to revise the
methodology for calculating the
hospital-specific limit for the
Disproportionate Share Hospital (DSH)
program. Specifically, SPA 14–25
proposed to exclude from the
calculation, the portion of a Medicare
payment for an individual who is

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dually-eligible for Medicare and
Medicaid that exceeds the Medicaid
allowable cost for the service provided
to the recipient. This exclusion would
permit the state to make Medicaid DSH
payments that are above and beyond
hospitals’ reported uncompensated
costs of providing services to Medicaid
and uninsured individuals.
The issue to be considered at the
hearing is:
• Whether Texas SPA 14–25 is
inconsistent with Medicaid DSH
requirements of sections 1902(a)(13)(A)(iv)
and 1923 of the Social Security Act (Act)
because it would provide for payment to
disproportionate share hospitals of amounts
that exceed the hospital’s uncompensated
costs which cannot be considered consistent
with DSH requirements pursuant to the
hospital-specific limit under section
1923(g)(1) of the Act.

Section 1116 of the Act and federal
regulations at 42 CFR part 430, establish
Department procedures that provide an
administrative hearing for
reconsideration of a disapproval of a
state plan or plan amendment. CMS is
required to publish a copy of the notice

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